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Trial Comparing Best Supportive Care to Aloe Vera Gel

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00876642
Recruitment Status : Completed
First Posted : April 7, 2009
Last Update Posted : April 7, 2009
Information provided by:
Marilia Medicine School

Brief Summary:

Radiation therapy (RT) has been a component of breast cancer treatment for almost 100 years. Although initially used for the treatment of chest wall recurrences after mastectomy and for advanced inoperable disease, RT has evolved into a critical component of early therapy for women with an intact breast following lumpectomy and for mastectomized women who are at high risk for local failure. Currently breast cancer patients need a multidisciplinary management including surgery, chemotherapy and radiotherapy, radiotherapy has a significant role in loco regional control of the disease. It is estimated that 87% of these women will develop some degree of radiation-induced dermatitis, varying from mild to brisk erythema or even moist desquamation.

Topical agents, such as corticosteroid creams and other products including Aquaphor (Beirsdorf Inc, Wilton, CT), and trolamine (Biafine; Genmedix Ltd, France), are commonly prescribed at the onset of radiation dermatitis or, in some institutions, at the beginning of radiotherapy.

The aim of this randomized phase III study was to assess the effectiveness of aloe vera cream for the prevention of acute radiation-induced dermatitis of grade 2 or higher during postoperative radiotherapy for breast cancer, compared to best supportive care. The secondary objectives were to assess pain, treatment interruption as a result of skin reactions, and the quantity of life during the treatment.

Condition or disease Intervention/treatment Phase
Radiation Dermatitis Drug: Aloe vera gel Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 137 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Phase III Trial Comparing Best Supportive Care to Aloe Vera Gel as a Prophylactic Agent for Radiation Induced Skin Toxicity
Study Start Date : March 2007
Actual Primary Completion Date : September 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Aloe vera

Arm Intervention/treatment
Experimental: 1 Drug: Aloe vera gel
The aloe vera gel which was commercially available, contained water, aloe vera, D-panthenol, triethanolamine, carbomer 934P, hyaluronic acid, potassium sorbate, diazolidinyl urea, methylparaben, and propylparaben.

No Intervention: 2

Primary Outcome Measures :
  1. Acute radiation-induced dermatitis of grade 2 or higher during postoperative radiotherapy for breast cancer.

Secondary Outcome Measures :
  1. quality of life,interruptions of treatment and pain.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • The women had to be 18 to 75 years of age with a nonmetastatic breast adenocarcinoma treated by either lumpectomy or mastectomy with or without adjuvant postoperative chemotherapy or hormonal treatment, and referred to the Department of Radiotherapy for postoperative radiotherapy. Concomitant chemotherapy was allowed.

Exclusion Criteria:

  • Women with bilateral cancer, patients who were allergic to either of the two agents, and pregnant women were excluded.
  • No rash, ulceration, bleeding, or unhealed scar was allowed in the treatment area.
  • Patients were excluded for: prior radiation therapy (RT), mastectomy, skin involvement by tumor, history of, or current connective tissue disorder, medical contraindication (allergy or sensitivity) to Aloevera or planned BSC, and inability to comply with treatment regime. The use of bolus was prohibited.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00876642

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Gustavo Viani
Marilia, Sao Paulo\brazil, Brazil, 17501570
Sponsors and Collaborators
Marilia Medicine School
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Responsible Party: Gustavo Viani Arruda, Marilia Medicine school Identifier: NCT00876642    
Other Study ID Numbers: Oncoclinica-2009-02
First Posted: April 7, 2009    Key Record Dates
Last Update Posted: April 7, 2009
Last Verified: April 2009
Keywords provided by Marilia Medicine School:
Radiation dermatitis
best supportive care
Aloe vera gel
phase III study was to assess the effectiveness of aloe vera and vitamin E.
Additional relevant MeSH terms:
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Skin Diseases
Radiation Injuries
Wounds and Injuries